Prevacid (Lansoprazole) - Indications and Dosage

INDICATIONS AND USAGE

PREVACID Delayed-Release Capsules, PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets and PREVACID For Delayed-Release Oral Suspension are indicated for:

SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER

PREVACID is indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer.

H. PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE

Triple Therapy: PREVACID/amoxicillin/clarithromycin

PREVACID in combination with amoxicillin plus clarithromycin as triple therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.)

Dual Therapy: PREVACID/amoxicillin

PREVACID in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY section.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.)

MAINTENANCE OF HEALED DUODENAL ULCERS

PREVACID is indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months.

SHORT-TERM TREATMENT OF ACTIVE BENIGN GASTRIC ULCER

PREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer.

HEALING OF NSAID-ASSOCIATED GASTRIC ULCER

PREVACID is indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks.

RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER

PREVACID is indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks.

GASTROESOPHAGEAL REFLUX DISEASE (GERD)

Short-Term Treatment of Symptomatic GERD

PREVACID is indicated for the treatment of heartburn and other symptoms associated with GERD.

Short-Term Treatment of Erosive Esophagitis

PREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis.

For patients who do not heal with PREVACID for 8 weeks (5-10%), it may be helpful to give an additional 8 weeks of treatment.

If there is a recurrence of erosive esophagitis an additional 8-week course of PREVACID may be considered.

MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS

PREVACID is indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months.

PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME

PREVACID is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

DOSAGE AND ADMINISTRATION

PREVACID is available as a capsule, orally disintegrating tablet and oral suspension, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms is presented below. PREVACID should be taken before eating. PREVACID products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with PREVACID.

No dosage adjustment is necessary in patients with renal insufficiency or the elderly. For patients with severe liver disease, dosage adjustment should be considered.

ADMINISTRATION OPTIONS

1. PREVACID Delayed-Release Capsules
   PREVACID Capsules-Oral Administration
   PREVACID Delayed-Release Capsules should be swallowed whole.
   Alternatively, for patients who have difficulty swallowing capsules, PREVACID Delayed-Release Capsules can be opened and administered as follows:
   
   • Open capsule.
   • Sprinkle intact granules on one tablespoon of either applesauce, ENSURE^® pudding, cottage cheese, yogurt or strained pears.
   • Swallow immediately.
   
   PREVACID Delayed-Release Capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:
   
   • Open capsule.
   • Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL - approximately 2 ounces).
   • Mix briefly.
   • Swallow immediately.
   • To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.
   
   USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.
   PREVACID Capsules - Nasogastric Tube Administration
   For patients who have a nasogastric tube in place, PREVACID Delayed-Release Capsules can be administered as follows:
   
   • Open capsule.
   • Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS.
   • Inject through the nasogastric tube into the stomach.
   • Flush with additional apple juice to clear the tube.
2. PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets
   PREVACID SoluTab should not be chewed. Place the tablet on the tongue and allow it to disintegrate, with or without water, until the particles can be swallowed. The tablet typically disintegrates in less than 1 minute.
   Alternatively, for children or other patients who have difficulty swallowing tablets, PREVACID SoluTab can be delivered in two different ways.
   PREVACID SoluTab - Oral Syringe
   For administration via oral syringe, PREVACID SoluTab can be administered as follows:
   
   • Place a 15 mg tablet in oral syringe and draw up approximately 4 mL of water, or place a 30 mg tablet in oral syringe and draw up approximately 10 mL of water.
   • Shake gently to allow for a quick dispersal.
   • After the tablet has dispersed, administer the contents within 15 minutes.
   • Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake gently, and administer any remaining contents.
   
   PREVACID SoluTab - Nasogastric Tube Administration (>/= 8 French)
   For administration via a nasogastric tube, PREVACID SoluTab can be administered as follows:
   
   • Place a 15 mg tablet in a syringe and draw up 4 mL of water, or place a 30 mg tablet in a syringe and draw up 10 mL of water.
   • Shake gently to allow for a quick dispersal.
   • After the tablet has dispersed, inject through the nasogastric tube into the stomach within 15 minutes.
   • Refill the syringe with approximately 5 mL of water, shake gently, and flush the nasogastric tube.
3. PREVACID for Delayed-Release Oral Suspension
   PREVACID for Delayed-Release Oral Suspension should be administered as follows:
   
   • Open packet.
   • To prepare a dose, empty the packet contents into a container containing 2 tablespoons of WATER. DO NOT USE OTHER LIQUIDS OR FOODS.
   • Stir well, and drink immediately.
   • If any material remains after drinking, add more water, stir, and drink immediately.
   • This product should not be given through enteral administration tubes.

HOW SUPPLIED

PREVACID Delayed-Release Capsules, 15 mg, are opaque, hard gelatin, colored pink and green with the TAP logo and "PREVACID 15" imprinted on the capsules. The 30 mg capsules are opaque, hard gelatin, colored pink and black with the TAP logo and "PREVACID 30" imprinted on the capsules. They are available as follows:

NDC 0300-1541-30 Unit of use bottles of 30: 15-mg capsules

NDC 0300-1541-19 Bottles of 1000: 15-mg capsules

NDC 0300-1541-11Unit dose package of 100: 15-mg capsules

NDC 0300-3046-13 Bottles of 100: 30-mg capsules

NDC 0300-3046-19 Bottles of 1000: 30-mg capsules

NDC 0300-3046-11Unit dose package of 100: 30-mg capsules

PREVACID for Delayed-Release Oral Suspension contains white to pale brownish lansoprazole granules and inactive pink granules in a unit dose packet. They are available as follows:

NDC 0300-7309-30 Unit dose carton of 30: 15-mg packets

NDC 0300-7311-30 Unit dose carton of 30: 30-mg packets

PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets, 15 mg, are white to yellowish white uncoated tablets with orange to dark brown speckles, with "15" debossed on one side of the tablet. The 30 mg are white to yellowish white uncoated tablets with orange to dark brown speckles, with "30" debossed on one side of the tablet. The tablets are available as follows:

NDC 0300-1543-30 Unit dose packages of 30: 15-mg tablets

NDC 0300-1544-30 Unit dose packages of 30: 30-mg tablets

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature]

Rx only

U.S. Patent Nos. 4,628,098; 4,689,333; 5,013,743; 5,026,560; 5,045,321; 5,093,132; 5,433,959; 5,464,632; 6,123,962 and 6,328,994.

Distributed by

TAP Pharmaceuticals Inc.

Lake Forest, IL 60045, U.S.A.

ENSURE® is a registered trademark of Abbott Laboratories.

CLOtest® is a registered trademark of Delta West Ltd., Bentley, Australia.

03-5366-R24 Rev. July, 2004

© 1995-2004 TAP Pharmaceutical Products Inc.

IN-5216/S